Usefulness of Tumor Heterogeneity Assessment in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET/CT Predicting Clinical Outcome

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography/computed tomography 18F-FDG PET/CT and a 18F-DCFPyL PET/CT (18F-DCFPyL (2-(3-{1-carboxy-5-\[(6-18F-fluoro-pyridine-3-carbonyl)-amino\]-pentyl}-ureido)-pentanedioic acid)positron emission tomography/computed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography/computed tomography ( Axumin PET/CT )will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET/CT will be acquired within 7 days from the PSMA PET. This study is open to Veterans only.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with mCRPC scheduled to undergo LuPSMA RLT.

• Willingness to undergo multiple serial PET/CT scans pre- and post-LuPSMA RLT.

• Ability of providing written informed consent.

Locations
United States
California
VA Greater Los Angeles Healthcare System
RECRUITING
Los Angeles
Contact Information
Primary
Gholam Berenji, MD
Gholam.Berenji@va.gov
310-268-3547
Backup
Janake Wijesuriya, BS
Janake.Wijesuriya@va.gov
310-977-5209
Time Frame
Start Date: 2024-12-15
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 15
Treatments
Experimental: 18F-Fluciclovine PET/CT
Subjects receive 18F-Fluciclovine PET/CT scans.
Related Therapeutic Areas
Sponsors
Leads: VA Greater Los Angeles Healthcare System

This content was sourced from clinicaltrials.gov